Ignite Creation Date:
2025-12-24 @ 7:14 PM
Ignite Modification Date:
2026-01-05 @ 6:07 PM
Study NCT ID:
NCT04827303
Status:
COMPLETED
Last Update Posted:
2021-04-01
First Post:
2021-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Different Methods in Acute Myofascial Pain Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005156', 'term': 'Facial Neuralgia'}], 'ancestors': [{'id': 'D005155', 'term': 'Facial Nerve Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-29', 'studyFirstSubmitDate': '2021-03-29', 'studyFirstSubmitQcDate': '2021-03-29', 'lastUpdatePostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual analog scale', 'timeFrame': '1 week', 'description': 'The pain at rest and during movement of the patients in all 3 groups were evaluated with a visual analog scale (VAS 10 cm).'}, {'measure': 'The number of trigger points', 'timeFrame': '1 week', 'description': 'The number of trigger points was determined by the physician by hand palpation.'}, {'measure': 'Pressure pain threshold', 'timeFrame': '1 week', 'description': 'Pressure pain threshold was evaluated with the algometer device.'}, {'measure': 'Neck pain disability index', 'timeFrame': '1 week', 'description': 'Disability assessment of the patients was made using the neck pain disability index.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myofacial Pain Syndromes']}, 'descriptionModule': {'briefSummary': "This study is a randomized controlled study. A total of 75 patients between the ages of 20-50 who have a diagnosis of acute myofacial pain syndrome in the trapezius muscle and have pain for a maximum of 5 days were included in the study. Patients were randomly divided into 3 groups. Group 1 patients received kinesio tape method (25 patients), group 2 patients received trigger point injection method (25 patients), and group 3 patients received neural therapy injection method (25 patients). A 10-15 cm sized I band was applied to the trapezius muscles of the first group patients with the patient's neck in lateral flexion. Then, while the patient's neck is flexed, a Y-shaped 15-20 cm tape will be affixed between C1-7 with the arms of the Y up, and I tape of 5-10 cm is attached on the arms. In group 2 patients, 1 cc lidocaine diluted with 4 cc saline (SF) was applied to the trigger points palpated manually in the trapezius muscles. After the trigger point was squeezed between the thumb and index finger, a few cc of local anesthetic mixture was applied into the trigger point with the injector and exited. In the 3rd group patients, a few cc local anesthetic mixture will be applied intradermally over the trigger point without entering into the trigger points palpated manually in the trapezius muscles. Patients were checked 72 hours and 1 week after the first applications.\n\nThe pain at rest and during movement of the patients in all 3 groups were evaluated with a visual analog scale (VAS 10 cm). The number of trigger points was determined by the physician by hand palpation. Pressure pain threshold was evaluated with the algometer device. Disability assessment of the patients was made using the neck pain disability index. evaluations were made at the beginning of treatment, 72 hours after and 1 week after treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'A total of 75 patients between the ages of 20-50 who have a diagnosis of acute myofacial pain syndrome in the trapezius muscle and have pain for a maximum of 5 days.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with acute myofascial pain syndrome\n* Patients between the ages of 20-50\n* Patients with pain for up to 5 days\n\nExclusion Criteria:\n\n* Patients diagnosed with fibromyalgia\n* Patients with systemic disease\n* Patients with prominent cervical disc herniation\n* Patients with cervical arthrosis\n* Patients with cervical radiculopathy and myelopathy\n* Patients with myofascial trigger point injection in the past 6 months\n* Patients who received physical therapy in the past 6 months\n* Patients undergoing shoulder and neck surgery\n* Patients with drug allergies'}, 'identificationModule': {'nctId': 'NCT04827303', 'briefTitle': 'Effectiveness of Different Methods in Acute Myofascial Pain Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Ufuk University'}, 'officialTitle': 'Effectiveness of 3 Different Methods in Acute Myofascial Pain Syndrome: A Randomized Controlled Study', 'orgStudyIdInfo': {'id': '29032017-8'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Kinesio taping', 'type': 'OTHER', 'otherNames': ['trigger point injection', 'neural therapy injection'], 'description': "A 10-15 cm sized I band was applied to the trapezius muscles of the first group patients with the patient's neck in lateral flexion. Then, while the patient's neck is flexed, a Y-shaped 15-20 cm tape will be affixed between C1-7 with the arms of the Y up, and I tape of 5-10 cm is attached on the arms. In group 2 patients, 1 cc lidocaine diluted with 4 cc saline (SF) was applied to the trigger points palpated manually in the trapezius muscles. After the trigger point was squeezed between the thumb and index finger, a few cc of local anesthetic mixture was applied into the trigger point with the injector and exited. In the 3rd group patients, a few cc local anesthetic mixture will be applied intradermally over the trigger point without entering into the trigger points palpated manually in the trapezius muscles. Patients were checked 72 hours and 1 week after the first applications."}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Ufuk University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'saime ay', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ufuk University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ufuk University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Doctor', 'investigatorFullName': 'Saime Ay', 'investigatorAffiliation': 'Ufuk University'}}}}